USA – FDA finalizes guidance on quantitative efficacy and risk info for DTC promotional...
The US Food and Drug Administration (FDA) has published final guidance on presenting risk and efficacy for direct-to-consumer (DTC) promotional labeling and advertisements for...
USA – FDA grants fast track designation to AC Immune’s Alzheimer’s disease vaccine
The candidate, ACI-24.060, will now benefit from the FDA’s fast track process, which is designed to improve the efficiency of product development and accelerate...
UK – Bristol Myers Squibb’s Sotyktu recommended by NICE for plaque psoriasis
The new guidance specifically applies to patients with a Psoriasis Area and Severity Index score of ten or more, a Dermatology Life Quality Index...
Europe – Procedural advice on publication of information on withdrawals of applications for marketing...
This paper describes the publication of information on the withdrawals of marketing authorisation applications for human medicinal products and withdrawals of applications for variations/extensions...
Europe – Use of real-world evidence in regulatory decision making – EMA publishes review...
Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments...
USA – FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Two new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended two medicines for approval at its June 2023 meeting.
The committee recommended granting a marketing...
USA – Pharmacogenomic data guidance: Industry objects to reporting exploratory studies
An industry group representing pharmaceutical and biotechnology companies is asking the US Food and Drug Administration (FDA) not to require the reporting of results...
USA – FDA’s drug quality report card details enforcement trends, increased inspections in 2022
In its latest State of Pharmaceutical Quality report, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) cited an increase in...
Europe – ACT EU: creating a better environment for clinical trials through collaboration
The Accelerating Clinical Trials in the EU (ACT EU) initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU)....
